Centivax has inked a strategic collaboration with the US Naval Medical Research Center (NMRC) to carry out Phase I trial of Centi-B9, its SARS-CoV-2 antibody.
Centi-B9 is intended to serve as a broad-spectrum therapeutic and prophylactic for administration through injections.
Furthermore, Centi-B9 is also expected to serve as an adjunct to vaccines for wider protection.
Engineered to neutralise the emergent Covid-19 mutated variants, the antibody has shown wide-spectrum reactivity against 99.5% of all strains in the US.
It also showed reactivity against over 98% of the strains seen across the world, including South African B.1.351, Brazilian P.1, UK B.1.1.7, New York B.1.526 and California B.1.429 strains.
The antibody is bioengineered to provide greater stability, reduced viscosity high concentration (250mg/ml) delivery. It facilitates a prophylactic or therapeutic dose that can be given even in a non-hospital setting through a single injection.
Using Xencor Xtend technology, Centi-B9 was engineered for enhanced safety and half life.
Under the collaboration, Centivax and NMRC will offer a principal investigator for the clinical study.
NMRC will conduct the Phase I trial centre for intramuscular and subcutaneous administration of Centi-B9 besides providing protocol development and medical management support.
Centivax CEO Dr David Gangemi said: “Our highly concentrated, thermostable, neutralising antibody fits the needs of the Navy, and DOD in general, in that it can be administered intramuscularly to warfighters in cramped quarters or austere environments to boost and extend protection already afforded by vaccination.
“Our antibody is highly effective against over 98% of the currently circulating variants and is a good fit for use in prolonged deployments when prophylaxis and/or post-exposure treatment is needed.”
The Henry Jackson Foundation is providing a non-dilutive funding of $4.2m for the clinical study.
This trial will validate Centi-B9’s safety and pharmacokinetics in healthy participants and is expected to commence in July.
The Phase I trial will facilitate a Phase II/III adaptive study later this year.
Centivax plans to submit an application to obtain Emergency Use Authorization (EUA) during the interim analysis of the trial.